Safely to Patients: Why Regulation and Quality Control Are Part of Innovation
For advanced therapies, regulation is an important part of development from its earliest stages. The hospital exemption is a separate, precisely defined regulatory tool that is assessed in the Czech Republic by the State Institute for Drug Control.
Innovation Needs Clear Rules
Regulation of advanced therapy medicinal products (ATMPs) represents the set of rules and procedures used to assess the development, manufacturing and use of medicines. The hospital exemption is one of these regulatory tools.
It allows an ATMP to be used under precisely defined conditions, for a specific patient, in a hospital and under the professional responsibility of a physician.
The State Institute for Drug Control (SÚKL) plays a key role in bringing advanced therapies into clinical practice. It acts not only as the national regulatory authority, but also as an institution whose expert work helps create safe conditions for innovative treatment to reach patients.
High-quality regulation is essential for advanced therapy medicinal products. These therapies are often intended for small groups of patients with limited treatment options and, because of the rarity, severity or specific nature of their diseases, require a highly individualised approach.
Thanks to the functioning regulatory environment in the Czech Republic and the work of SÚKL, the Centre of Excellence CREATIC at the Faculty of Medicine, Masaryk University was granted the first hospital exemption for an advanced therapy medicinal product in the Czech Republic.
Regulation of advanced therapy medicinal products (ATMPs) represents the set of rules and procedures used to assess the development, manufacturing and use of medicines. The hospital exemption is one of these regulatory tools.
It allows an ATMP to be used under precisely defined conditions, for a specific patient, in a hospital and under the professional responsibility of a physician.
The State Institute for Drug Control (SÚKL) plays a key role in bringing advanced therapies into clinical practice. It acts not only as the national regulatory authority, but also as an institution whose expert work helps create safe conditions for innovative treatment to reach patients.
High-quality regulation is essential for advanced therapy medicinal products. These therapies are often intended for small groups of patients with limited treatment options and, because of the rarity, severity or specific nature of their diseases, require a highly individualised approach.
Thanks to the functioning regulatory environment in the Czech Republic and the work of SÚKL, the Centre of Excellence CREATIC at the Faculty of Medicine, Masaryk University was granted the first hospital exemption for an advanced therapy medicinal product in the Czech Republic.
What Requirements Must a Hospital Exemption Meet?
The hospital exemption allows an advanced therapy medicinal product without standard marketing authorisation to reach a specific patient under precisely defined conditions when no other suitable treatment is available or existing treatment is not effective. It is an expert-led and controlled process based on requirements for the quality and safety of the medicinal product and on ongoing evaluation of its effectiveness.
Manufacturing must comply with strict Good Manufacturing Practice requirements. Compliance with the defined conditions is assessed not only before the hospital exemption is authorised, but throughout its duration, including administration of the medicinal product to patients and subsequent follow-up of treatment.
The hospital exemption allows an advanced therapy medicinal product without standard marketing authorisation to reach a specific patient under precisely defined conditions when no other suitable treatment is available or existing treatment is not effective. It is an expert-led and controlled process based on requirements for the quality and safety of the medicinal product and on ongoing evaluation of its effectiveness.
Manufacturing must comply with strict Good Manufacturing Practice requirements. Compliance with the defined conditions is assessed not only before the hospital exemption is authorised, but throughout its duration, including administration of the medicinal product to patients and subsequent follow-up of treatment.
When Regulation Helps Treatment Reach Patients
The cooperation between SÚKL and CREATIC shows that well-designed regulation can be an active part of the pathway that brings innovative treatment to patients. Through this approach, the Czech Republic builds on the practice of European healthcare systems that safely connect research, manufacturing, clinical care and regulation for the benefit of patients.
We greatly value the regulatory support that the State Institute for Drug Control provides to academic and non-profit organisations, as well as its approach to the development of innovative therapies. This helps modern treatment reach the patients who need it more quickly.
Regulation, manufacturing and clinical use therefore form one interconnected whole within the hospital exemption framework. The Czech experience from 2026 does not stand alone: similar regulatory pathways are used in other European countries. In the final article in the series, we place the first Czech hospital exemption in a broader European context.
The cooperation between SÚKL and CREATIC shows that well-designed regulation can be an active part of the pathway that brings innovative treatment to patients. Through this approach, the Czech Republic builds on the practice of European healthcare systems that safely connect research, manufacturing, clinical care and regulation for the benefit of patients.
We greatly value the regulatory support that the State Institute for Drug Control provides to academic and non-profit organisations, as well as its approach to the development of innovative therapies. This helps modern treatment reach the patients who need it more quickly.
Regulation, manufacturing and clinical use therefore form one interconnected whole within the hospital exemption framework. The Czech experience from 2026 does not stand alone: similar regulatory pathways are used in other European countries. In the final article in the series, we place the first Czech hospital exemption in a broader European context.
Continue the series
Next article: Hospital Exemption in Europe: Different Paths, a Common Goal